Sleep Disorders Clinical Trial
Official title:
Daily Light Intervention in Renal Transplant Recipients Having a Sleep-Wake Dysregulation
Sleep-wake dysregulation is a disturbance in the roughly 24-hour cycle of the circadian
rhythm. Well known disorders presenting a sleep-wake dysregulation are seasonal affective
disorder, jet lag and shift work. These people experience a serious mood change when the
seasons change. When the day-night rhythm is desynchronized, they have sleep disturbances,
little energy, and often feel depressed. An established intervention to treat this disorder
is bright light therapy. Light therapy is used for affective disorders for shift workers,
jet lag symptomatology and for advancing or delaying desynchronized rhythms.Two proxy
measures for sleep-wake dysregulation are sleep quality and daytime sleepiness. It is known
from cross sectional studies that renal transplant (RTx) recipients have a prevalence
between 30% to 62% of poor sleep quality measured by self report; a prevalence of impaired
daytime functioning of 34% 12 and a prevalence of depressive symptomatology of 20% to 22%.
Sleep-wake dysregulation in other chronically ill population are a risk factor for morbidity
and mortality.
RTx nurses in the follow-up care are in the frontline for recipient's symptoms respectively
problems. The psychosocial variables that should be addressed, having an association with
morbidity and mortality are sleep, daytime functioning, adherence to immunosuppressive
medication, exercise, smoking and depressive symptomatology.
In the following research project we will address the following gaps: the fact that nature
of sleep disturbances in RTx recipients has never been assessed, that there is no prevalence
available on sleep-wake dysregulation and that there is no data on bright light therapy
intervention in RTx recipients.
Hypothesis: Renal transplant recipients having a sleep wake disregulation will have an
improved sleep quality and less daytime sleepiness after 21 days of light therapy.
This research project has three phases:
The first phase is a cross sectional survey including all patients transplanted in Basel,
Bern and in Zurich speaking German and transplanted at least 6 months ago. Renal transplant
recipients having poor sleep quality and / or daytime sleepiness as result of this first
phase will be asked to participate in phase two. Phase two is an sleep assessment, resulting
in a presumed sleep diagnosis.
Renal transplant recipients having a sleep wake dysregulation, assessed in phase two, will
be asked to participate in phase three. Phase three is a pilot randomized controlled trial
to compare the sustained impact of bright light therapy on sleep-wake regulation.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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